BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2090884 · Received April 26, 2011

    Report

    Report Number
    3004209178-2011-03113
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 3, 2011
    Report Date
    April 8, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A RETURN OF PT SYMPTOMS THAT BEGAN (B)(6). THE PT HAD PAIN THAT TRAVELED DOWN THE LEG TO THE ANKLE, AND THE PAIN WAS THE SAME PAIN AS BEFORE THE STIMULATOR WAS IMPLANTED. THE PT HAD NO TRAUMA OR FALLS "RECENTLY." WHEN THE STIMULATION WAS INCREASED, THERE WAS ALSO AN UNCOMFORTABLE STIMULATION EFFECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB073445V| LEAD: MODEL 39565-30, LOT# V435030004| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB067626V| PROGRAMMER: MODEL 37743, LOT# NKE147599N| IMPLANTED:| IMPLANTED: